The FDA com­plet­ed less than half (48%) of its reg­u­la­to­ry ac­tions for phar­ma fa­cil­i­ties des­ig­nat­ed as OAI or with an Of­fi­cial Ac­tion In­di­cat­ed, with­in 6 months of an in­spec­tion clos­ing, ac­cord­ing to the lat­est re­port from the agency on the ef­fects Covid-19 had on gen­er­al over­sight at man­u­fac­tur­ing sites last year.

The agency al­so lost pace in is­su­ing fi­nal fa­cil­i­ty clas­si­fi­ca­tion let­ters.

In FY 2021, the re­port not­ed FDA is­sued 70% of fi­nal fa­cil­i­ty clas­si­fi­ca­tion let­ters with­in 90 days of in­spec­tion clos­ing. By com­par­i­son, in FY 2019, 87% of fi­nal fa­cil­i­ty clas­si­fi­ca­tion let­ters were is­sued with­in 90 days of in­spec­tion clos­ing, and com­plet­ed 74% of reg­u­la­to­ry ac­tions for OAI fa­cil­i­ties.

Pan­dem­ic mit­i­ga­tion ef­forts such as trav­el re­stric­tions have im­pact­ed the num­ber of in­spec­tions con­duct­ed by the FDA as re­sources were be­ing di­vert­ed to the pan­dem­ic re­sponse.

The back­log at the FDA has been well doc­u­ment­ed. In 2021, the Gov­ern­ment Ac­count­abil­i­ty Of­fice de­tailed that the FDA did not con­duct any new in-per­son in­spec­tions of Covid-19 vac­cine man­u­fac­tur­ing plants be­fore is­su­ing the EUAs for Pfiz­er, Mod­er­na and J&J’s shots. Mean­while, the agency in­stead had to re­ly on his­tor­i­cal find­ings for the 18 man­u­fac­tur­ing sites.

While the FDA is­sued mea­sures on con­duct­ing vir­tu­al eval­u­a­tions to get a han­dle on the back­log, there were still ma­jor lim­i­ta­tions to the re­mote pro­gram, and it on­ly filled a frac­tion of the in­spec­tions in the agency’s back­log.

The num­bers for 2022 will most like­ly not im­prove too much as even ear­li­er this year, the FDA qui­et­ly an­nounced it once again paused all its non-mis­sion-crit­i­cal in­spec­tions in the US, but those in­spec­tions have since re­turned to nor­mal.

Al­though more in­spec­tions, Form 483s, and warn­ing let­ters are start­ing to roll out again, the agency has a lot of catch­ing up to do if it wants to re­turn to pre-pan­dem­ic lev­els.

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

As the manufacturing of cell and gene therapies is ramping up and companies are starting to invest in their manufacturing capabilities, Terumo Blood and Cell Technologies have formed a partnership to stay in the game.

According to the company, it has signed a new collaborative agreement with GenCure, a subsidiary of BioBridge Global, to extend and unify cell and gene therapy manufacturing solutions.

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.